. /.  WORLD TRADE  
ORGANIZATION   
G/SPS/N/CAN/585 
26 January 2012  
 (12-0510) 
Committee on Sanitary and Phytosanitary Measures Original:   English/ 
 French 
 
 
 
NOTIFICATION 
 
1. Notifying Member:  CANADA 
If applicable, name of local government involved:    
2. Agency responsible:  Health Canada 
3. Products covered (provide tariff item numbe r(s) as specified in national schedules 
deposited with the WTO;  ICS numbers should be provided in addition, where 
applicable):  Bread, flour, whole wheat flour and unsta ndardized bakery products such as 
cookies and cakes (ICS Codes:  67.060, 67.220) 
4. Regions or countries likely to be affected, to the extent relevant or practicable: 
[X] All trading partners   
[ ] Specific regions or countries:    
5. Title of the notified document:  Interim Marketing Authorization regarding the use of 
xylanase derived from Bacillus subtilis strain XAS in the production of bread, flour, whole 
wheat flour and unstandardized bakery products such as cookies and cakes  Language(s):  
English and French  Number of pages:  2 
6. Description of content:  Health Canada has received a submission to permit the use of 
xylanase derived from Bacillus subtilis strain XAS in the production of bread, flour, whole 
wheat flour and unstandardized bakery prod ucts such as cookies and cakes at levels 
consistent with good manufacturing practice.  Evaluation of available data supports the 
safety and effectiveness of xylanase derive d from Bacillus subtilis (XAS) in these food 
products.  
Therefore, it is the intention of Health Ca nada to recommend that the Regulations be 
amended to permit the use of xylanase deri ved from Bacillus subtilis (XAS) in the 
production of bread, flour, whole wheat flour an d unstandardized bakery products at levels 
consistent with good manufacturing practice.  
As a means to improve the responsiveness of th e regulatory system, an Interim Marketing 
Authorization (IMA) is being issued to perm it the immediate use of this xylanase enzyme, 
as indicated above, while the regulatory pro cess is undertaken to amend the Regulations. 
The proposed regulatory amendments would be  enabling measures to allow the sale of the 
additional foods mentioned above  that have been manufactured through the use of xylanase 
derived from Bacillus subtilis (XAS).  Th e amendments are supported by the safety 
assessment and would have low impact on the economy and on the environment. 
Consequently, the regulatory amendments ma y proceed directly to final approval and 
publication in the Canada Gazette , Part II. G/SPS/N/CAN/585 
Page 2  
 
  7. Objective and rationale:  [X] food safety, [ ] animal health, [ ] plant protection, 
[ ] protect humans from animal/plant pest or disease, [ ] protect territory from other 
damage from pests.    
8. Is there a relevant international stan dard?  If so, identify the standard:  
[ ] Codex Alimentarius Commission (e.g.  title or serial number of Codex standard 
or related text)   
[ ] World Organization for Animal Health (OIE) (e.g. Terrestrial or Aquatic 
Animal Health Code, chapter number)    
[ ] International Plant Protection Convention (e.g. ISPM number)    
[X] None Does this proposed regulation conform to the relevant international standard?   
 [ ] Yes   [ ] No 
 If no, describe, whenever possible, how and why it deviates from the 
international standard:    
9. Other relevant documents and language (s) in which these are available:  Canada 
Gazette , Part I, 14 January 2012, Pages 28-29 (available in English and French) 
10. Proposed date of adoption (dd/mm/yy) :  Immediate for this IMA.  For the final regulation, 
normally within 12-18 months of publication of the Notice of Interim Marketing 
Authorization in the Canada Gazette , Part I, 14 January 2012. 
Proposed date of publication (dd/mm/yy) :    
11. Proposed date of entry into force:  [ ] Six months from date of publication , and/or  
(dd/mm/yy) :  Immediate for this IMA.  For the fi nal regulation, normally within 12-18 
months of publication of the Notice of Interim Marketing Authorization in the Canada 
Gazette , Part I, 14 January 2012. 
[ ] Trade facilitating measure   
12. Final date for comments:  [ ] Sixty days from the date of circulation of the notification 
and/or (dd/mm/yy) :  29 March 2012 
Agency or authority designated to handl e comments:  [ ] National Notification 
Authority, [X] National Enquiry Point.  Address, fax number and e-mail address (if 
available) of other body:    
13. Texts available from:  [ ] National Notification  Authority, [X] National Enquiry Point.  
Address, fax number and e-mail address (if available) of other body:    
The electronic version of the regulatory text can be downloaded at:   
http://www.gazette.gc.ca/rp-pr/p1/201 2/2012-01-14/pdf/g1- 14602.pdf#page=8  ( Canada 
Gazette ) 
or  http://www.gazette.gc.ca/rp-pr/p1/2012/ 2012-01-14/html/notice-avis-eng.html#d106  
(English) 
http://www.gazette.gc.ca/rp-pr/p1/2012/ 2012-01-14/html/notice-avis-fra.html#d106  
(French)